XVIl International perfumery and cosmetics exhibition
17-19 September 2019 • IEC, Kyiv, Ukraine
17-18 September - 10:00 до 18:00 | 19 September - 10:00 до 17:00

LEGALIZATION OF IMPORTS

News
For the Ukrainian market of aesthetic medicine and professional cosmetology
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Following the events of 2014, Ukraine started its development oriented towards the European Union. On September 1, 2017, the Agreement between Ukraine and the EU became effective. Ukraine undertook a commitment to follow the path of harmonization with the EU legislation, and as a result, some changes were made in the regulatory documents of the healthcare sector.
 
The nomenclature of the products for the market of esthetic medicine and professional cosmetology can be provisionally divided into 2 categories of goods, the production and sale of which in the EU is strictly regulated:
 
  1. Beauty products, cosmeceutics
 
  1. Medical devices:
 
  • Fillers administered into the human tissues by injections (fillers, biorevitalization agents, etc.)
 
  • Threads for tightening and strengthening of facial and body tissues, including ones in the needles and cannulas
 
  • Needles for injection procedures (revitalization, mesotherapy, etc.). Cannulas for filling, and revitalization, liposuction, etc.
 
  • Equipment with consumables (laser and dermatological systems, centrifuges, test tubes for PRP therapy, etc.)
 
In addition to these main categories, there can still be combined forms, which are equally subjects of European legislation.
 
Cosmetic products which in the EU should comply with EU Regulation No. 1223/2009 "On Cosmetic Products" (REGULATION (EC) No 1223/2009):
 
  • Creams, emulsions, lotions, gels and skin oil;
  • Facial masks;
  • Makeup bases (liquids, pastes, powders), powders;
  • Perfumery, toilet water, colognes;
  • Products for bath and shower (salts, foams, oils, gels);
  • Talc for body after taking bath, hygienic talc;
  • Toilet soap, deodorant soap;
  • Depilators, deodorants and antiperspirants;
  • Hair dyes, hair curling, straightening and fixing preparations, hair styling preparations;
  • Products for hair cleaning (lotions, talc, shampoos), hair conditioners (lotions, creams, oils);
  • Products for hair care (lotions, hair sprays, hair brilliantines);
  • Products for make-up and for makeup removal;
  • Products for lip care;
  • Products for the teeth and oral cavity care;
  • Products for nail care and manicure products;
  • Sunbathing products; skin tanners;
  • Skin whitening and anti-wrinkle products;
  • Products for shaving (creams, foams, lotions);
  • Intimate hygiene products for external use.
 
For today, a number of commitments stipulated by the Agreements on Conformity Assessment and Acceptance of Industrial Goods (ACAA) between Ukraine and the EU have been partially implemented, so Ukraine should prepare a Technical Regulation based on the relevant EU Directive.
 
In 2010, the work on preparing such a Technical Regulation was started. Based on the preliminary analysis performed by the State Regulatory Service, a number of remarks for mandatory performance have been made. After eliminating these remarks, the above-mentioned document will regulate the circulation of cosmetic products within the territory of Ukraine.
 
In accordance with the Law of Ukraine "On Ensuring the Sanitary and Epidemiological Well-Being of the Population", in order to import and sale the cosmetic products, it is required to obtain a conclusion of the sanitary and epidemiological expert committee, which is entered into the corresponding Register of Conclusions of the State Sanitary and Epidemiological Expert Committee. The issuance of this document is carried out by the State Service of Ukraine for Food Safety and Consumer Protection, on the basis of the performed laboratory tests and analysis of the submitted dossier.
 
img-intercharm-news-2.pngThe conclusion of the State Sanitary and Epidemiological Expert Committee contains the list of mandatory information for the distributor:
 
  • Scope of sale (wholesale and retail trade, pharmacy networks (as a companion product));
 
  • Manufacturer’s location;
 
  • УКТЗЕД code (Ukrainian Classifier of Goods for Foreign Economic Activity), which determines the size of import duties;
 
  • For cosmeceutics, at the Applicant’s discretion, the scope of sale can be specified as “beauty salons”.
 
The second part of the products belongs to medical devices, since in the EU their manufacture and sale are regulated by the relevant Directives. From July 1, 2017, new rules were introduced in Ukraine for the import and sale of medical devices, as the Technical Regulations (CMU Regulation No. 753 dated October 2, 2013 and CMU Regulation No. 754 dated October 2, 2013), which are based on the relevant European Directives 93/42/EЕС and 98/79/EEC, became effective. Due to the fact that these Directives have already been updated in the EU, in the coming years corresponding upgrade will take place in Ukraine as well.
 
Accordingly, in order to determine whether the products belong to the category of medical devices or not, the Ukrainian conformity assessment body will apply the relevant European documents. The main of them is the Guidance on Demarcation and Classification within the Framework of Public Regulation for Medical Devices, Version 1.19 of April 2018. In addition, there are several documents, complementing the main document.
 
If the products are recognized as medical devices, the conclusions of the State Sanitary and Epidemiological Expert Committee are not required for the customs clearance (CMU Resolution No. 44 dated January 31, 2018 “On Amendments to Decrees of the Cabinet of Ministers of Ukraine No. 1031 dated October 5, 2011 and dated May 25, 2016.)
 
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To import medical devices into Ukraine, first you need to go through the conformity assessment procedure with the Technical Regulations requirements and obtain the Certificate of Conformity. Depending on the product risk class and some other factors, there are 4 schemes for going through this procedure:
 
1. Self-declaration
2. Testing the product batch
3. Audit of the quality management system
4. Recognition of CE certificates
 
The rules defining the class of potential risk of a medical device are specified in the Technical Regulations. However, the decision on assignment of the product to a "medical" or "cosmetic” category is made by the Manufacturer based on the current local legislation. After that, the product dossier should be prepared. In the event of disputable situation regarding the determination of product status, the Manufacturer or Manufacturer's representative may apply to the Ukrainian designated conformity assessment body for a clarification letter regarding the category of the medical device.
 
img-intercharm-news-4.pngOf particular interest to importers having CE certificates for their products, is the latter scheme, because it allows to save significant time and finances compared with the on-site audit of manufacture. However, its use is associated with several limitations that can be surmounted by not all notified bodies. Ukrainian Scientific Institute of Certification has the most experience in Ukraine in conducting the procedure for recognition of CE certificates for medical devices and, correspondingly, it has signed contracts with the leading European notified bodies.
 
Yevheniia Andriushchenko, CRATIA
 
Mykhailo Vakhrushev, Ukrainian Scientific Institute of Certification